Safety and efficacy of an endovascular-first approach to acute limb ischemia.

BACKGROUND: The optimal techniques to manage acute limb ischemia (ALI) remain unclear. Previous reports have suggested that the decreased morbidity and mortality of endovascular approaches are mitigated by the limited technical success rates relative to open or hybrid approaches for ALI. However, these data failed to include newer technologies that might improve the technical success rates. We, therefore, sought to describe the current outcomes for an endovascular-first approach to ALI. METHODS: We performed a single-center, single-arm, retrospective cohort study of consecutive patients with ALI from 2015 to 2018. Technical success, limb salvage, survival, patency, and length of stay were quantified using Kaplan-Meier (KM) analysis. Cox regression analysis was used to identify the predictors of amputation-free survival. RESULTS: During the 3 years, 60 consecutive patients (39 men [65%]; median age, 65 years) presented with ALI. The Rutherford class was I in 15 patients (25%), IIa in 23 (38%), IIb in 13 (22%), and III in 9 patients (15%). Of the 60 patients, 34 had a history of previous failed ipsilateral revascularization (56%), including open bypass for 8 (13%), endovascular for 8 (13%), and both open and endovascular intervention for 18 (30%). The endovascular-first approach procedures included catheter-directed thrombolysis only (n = 19; 3%), catheter-directed thrombolysis plus aspiration and/or rheolytic thrombectomy (n = 19; 32%), and aspiration and/or rheolytic thrombectomy (n = 16; 26%). Six patients (10%) underwent covered stent placement only. The underlying occlusive process was most often thrombosis of a previous bypass graft or stent in 32 patients (53%), followed by native vessel thrombosis in 15 (25%). ALI had resulted from embolism in 13 patients (21.7%), including 2 (3%) with embolization to occlude a previous bypass graft or stent. Technical success was achieved in 58 patients (97%), with open conversion required in two patients (3%). At 30 days postoperatively, 52 patients (87%) survived, and 53 (88%) had successful limb salvage. Five patients (8%) had required four-compartment fasciotomy. No major hemorrhagic complications developed. The median length of stay overall and in the intensive care unit was 9 days (interquartile range, 4-14 days) and 2 days (interquartile range, 1-5 days), respectively. At 1 year, the KM estimates were as follows: amputation-free survival, 58% ± 0.08%; limb salvage, 74.3% ± 0.07%; and survival, 73.3% ± 0.07%. The 1-year KM estimates for primary and secondary patency were 39.4% ± 0.08% and 78.2% ± 0.07%, respectively. On multivariable Cox regression analysis, only age independently predicted for death and/or amputation at the last follow-up (hazard ratio, 1.06; 95% confidence interval, 1.01-1.10; P = .01). CONCLUSIONS: The current endovascular approaches to ALI have high technical success rates. Survival, limb salvage, perioperative complications, and length of stay were similar to those from previous reports of historical open cohorts. Further prospective, appropriately powered, multicenter cohort studies are warranted to evaluate the efficacy of endovascular vs open approaches to ALI.

Endovascular Therapy in an "All-Comers" Risk Group for Chronic Limb-Threatening Ischemia Demonstrates Safety and Efficacy When Compared with the Established Performance Criteria Proposed by the Society for Vascular Surgery.

BACKGROUND: The aim of this study was to describe the applicability of the Society for Vascular Surgery (SVS) objective performance goals (OPGs) as a tool to evaluate results in the context of endovascular management of noncomplex and complex patients (i.e., end stage renal disease/history of prosthetic conduit) with chronic limb-threatening ischemia (CLTI). METHODS: Patients diagnosed with CLTI undergoing endovascular procedures from March 2016 to April 2017 were included, and medical records were examined. Patients were categorized as OPG risk (OPGR) and non-OPG risk (nOPGR) groups in accordance with the SVS performance criteria. We compared clinical events between the two groups and then further to the SVS OPGs. Thirty-day outcomes (safety) were major amputation (AMP), major adverse limb events (MALEs), and major adverse cardiovascular events (MACEs), and 1-year outcomes (efficacy) were limb salvage, MALE + 30-day perioperative death (MALE + POD), and survival. Mortality was demonstrated using Kaplan-Meier analysis. RESULTS: A total of 72 patients were included (OPGR = 58.3% vs. nOPGR = 41.7%). Mean follow-up was 20 months (range, 1-40 months). Retrograde pedal access was used in 65.2% of patients. The overall AMP rate was 2.7% (OPGR = 4.7%, nOPGR = 0%, P = 0.225, vs. SVS OPG<3%), MALE was 4.1% (OPGR = 7.1%, nOPGR = 0%, P = 0.135, vs. SVS OPG<8%), and MACE was 6.9% (OPGR = 2.3%, nOPGR = 13.3%, P = 0.071, vs. SVS OPG<8%). The limb salvage was 90.3% (OPGR = 88%, nOPGR = 93.3%, P = 0.46, vs. SVS OPG>84%), MALE + POD was 76.4% (OPGR = 78.6%, nOPGR = 73.4%, P = 0.606, vs. SVS OPG>71%), and survival was 77.7% (OPGR = 83.3%, nOPGR = 70%, P = 0.18, vs. SVS OPG>80%). CONCLUSIONS: The SVS OPGs set appropriate safety and efficacy standards as a bar for new technologies. In this series, endovascular therapy in all-comers exceeded the safety and efficacy endpoints proposed by the limited risk OPG panel.

Association Between Wearable Device-Based Measures of Physical Frailty and Major Adverse Events Following Lower Extremity Revascularization.

Importance: Physical frailty is a key risk factor associated with higher rates of major adverse events (MAEs) after surgery. Assessing physical frailty is often challenging among patients with chronic limb-threatening ischemia (CLTI) who are often unable to perform gait-based assessments because of the presence of plantar wounds. Objective: To test a frailty meter (FM) that does not rely on gait to determine the risk of occurrence of MAEs after revascularization for patients with CLTI. Design, Setting, and Participants: This cohort study included 184 consecutively recruited patients with CLTI at 2 tertiary care centers. After 32 individuals were excluded, 152 participants were included in the study. Data collection was conducted between May 2018 and June 2019. Exposures: Physical frailty measurement within 1 week before limb revascularization and incidence of MAEs for as long as 1 month after surgery. Main Outcomes and Measures: The FM works by quantifying weakness, slowness, rigidity, and exhaustion during a 20-second repetitive elbow flexion-extension exercise using a wrist-worn sensor. The FM generates a frailty index (FI) ranging from 0 to 1; higher values indicate progressively greater severity of physical frailty. Results: Of 152 eligible participants (mean [SD] age, 67.0 [11.8] years; 59 [38.8%] women), 119 (78.2%) were unable to perform the gait test, while all could perform the FM test. Overall, 53 (34.9%), 58 (38.1%), and 41 (27.0%) were classified as robust (FI <0.20), prefrail (FI ≥0.20 to <0.35), or frail (FI ≥0.35), respectively. Within 30 days after surgery, 24 (15.7%) developed MAEs, either major adverse cardiovascular events (MACE; 8 [5.2%]) or major adverse limb events (MALE; 16 [10.5%]). Baseline demographic characteristics were not significantly different between frailty groups. In contrast, the FI was approximately 30% higher in the group that developed MAEs (mean [SD] score, 0.36 [0.14]) than those who were MAE free (mean [SD] score, 0.26 [0.13]; P = .001), with observed MAE rates of 4 patients (7.5%), 7 patients (12.1%), and 13 patients (31.7%) in the robust, prefrail and frail groups, respectively (P = .004). The FI distinguished individuals who developed MACE and MALE from those who were MAE free (MACE: mean [SD] FI score, 0.38 [0.16]; P = .03; MALE: mean [SD] FI score, 0.35 [0.13]; P = .004) after adjusting by body mass index. Conclusions and Relevance: In this cohort study, measuring physical frailty using a wrist-worn sensor during a short upper extremity test was a practical method for stratifying the risk of MAEs following revascularization for CLTI when the administration of gait-based tests is often challenging.

Percutaneous coronary intervention in octogenarian patients / Intervención coronaria percutánea en pacientes octogenarios

Abstract: Introduction: Octogenarian patients are usually excluded from studies in which the effectiveness of percutaneous coronary intervention (PCI) is compared. Objective: Our aim is to compare this procedure among octogenarians and those younger; in addition to comparing the radial access (RA) and femoral access (FA) in patients older than 80 years. Material and methods: This is a retrospective, observational, comparative, longitudinal, single-center study. Patients who have been referred for PCI, from 2010 to 2016 in Monterrey, Nuevo Leon, Mexico were included. The groups were divided into the octogenarians group (OG) and a group of younger than 80 years (YG). Results: A total of 1,282 patients were collected, of whom 92 were of the OG and 1,190 were of the YG. The FA was the most used. Similar levels of radiation time (RT), radiation dose (DR), and amount of administered contrast medium (CM), vascular complications (VC) and mortality between the two groups were found. However, the OG had more length of hospital stay (LHS). Comparing the FA against RA in the OG there were no differences in RT, RD, amount of CM, VC, death and LHS. Conclusion: The results are similar between the two groups, with a greater tendency to more LHS in the OG. There were not significant differences between the RA and FA in the OG, except that LHS in the FA.

Resumen: Introducción: Los pacientes octogenarios son usualmente excluidos de los estudios en los cuales se compara la efectividad de las intervenciones coronarias percutáneas. Objetivo: Nuestro objetivo es comparar este procedimiento entre los pacientes octogenarios y aquéllos más jóvenes; además se compara el abordaje radial y el abordaje femoral en los pacientes octogenarios. Material y métodos: Éste es un estudio retrospectivo, observacional, comparativo, longitudinal, unicéntrico. Se realizó con aquellos pacientes que se refirieron para realización de un intervencionismo coronario percutáneo, en Monterrey, Nuevo León, México del 2010 al 2016. Los grupos se dividieron en el grupo de pacientes octogenarios y el grupo de pacientes menores de 80 años. Resultados: Se recabó un total de 1,282 pacientes, de los cuales 92 eran pacientes octogenarios, mientras que 1,190 fueron más jóvenes. En ambos el abordaje femoral fue el más utilizado. Se encontraron valores similares de dosis de radiación, tiempo de radiación, cantidad de contraste administrado, complicaciones vasculares y mortalidad entre los dos grupos. Sin embargo, los pacientes octogenarios tuvieron más días de estancia hospitalaria. Al comparar el abordaje femoral y el radial en octogenarios no se encontraron diferencias en dosis de radiación, tiempo de radiación, cantidad de medio de contraste, complicaciones vasculares, muerte y días de estancia hospitalaria. Conclusiones: Los resultados fueron similares entre ambos grupos de edad, con una mayor tendencia de estancia hospitalaria en octogenarios. No se encontraron diferencias significativas entre ambos abordajes en pacientes octogenarios, a excepción de mayores días de estancia hospitalaria en el abordaje femoral.

Contrast-induced nephropathy in patients undergoing percutaneous coronary intervention / Nefropatía inducida por medio de contraste en angiografías coronarias

Abstract: Introduction: Contrast-induced nephropathy (CIN) is defined as the impairment of renal function and is measured as either a 25% increase in serum creatinine (SCr) from baseline or 0.5 mg/dL increase in absolute value, within 48-72 hours of intravenous contrast administration. Objectives: Objectives were to calculate incidence of CIN and to describe the clinical and periprocedural risk factors for patients receiving contrast media. Secondary objective was to compare mortality between group 1 and group 2. Material and methods: In a retrospective, observational, descriptive cohort study, patients who were admitted to the hospital for diagnostic and/or therapeutic coronary angiography between January 2014 to September 2015, the serum creatinine and glomerular filtration rate (GFR) prior to angiography and 72 hours later was measured. Results: 70 patients were included, of which 14.2% developed CIN. The leading risk factors for developing AKI were: age > 65 years (OR 12.6, CI95 1.6-105.9, p = 0.03); the presence of anemia (OR 7.5, CI95 1.8-31.2, p = 0.006); and procedural time more than 90 minutes (OR 16, CI95 3.1-85.3, p = 0.001). Higher mortality was observed in the NIC group (30% vs. 1.6%, p = 0.004). Conclusions: The incidence is higher than in the literature review. The leading associated risk factors were age > 65, anemia and procedural time > 90 minutes. The development of CIN carries a higher mortality.

Resumen: Introducción: Se define como nefropatía inducida por medio de contraste (NIC) a un aumento absoluto de la creatinina sérica mayor a 0.5 mg/dL o un aumento relativo de la creatinina sérica mayor al 25%, 48-72 horas posteriores a la exposición al medio de contraste en comparación con los niveles previos después de haber excluido otras causas de lesión renal aguda (LRA). Objetivo: Determinar la incidencia de NIC y analizar los factores de riesgo asociados en los pacientes que desarrollaron LRA posterior a un procedimiento de angiografía coronaria. Se determinó mortalidad entre ambos grupos como objetivo secundario. Material y métodos: Se realizó un estudio de cohortes, observacional, descriptivo y retroelectivo. Se analizaron los pacientes que ingresaron en enero de 2014 a septiembre de 2015, para angiografía coronaria diagnostica y/o terapéutica. Se determinó la creatinina sérica y tasa de filtración glomerular (TFG) previa a la angiografía y 72 horas; además se identificaron los factores de riesgo asociados al desarrollo de NIC. Resultados: Se incluyeron 70 pacientes, de los cuales 14.2% desarrollaron NIC. Los factores de riesgo predictores más importantes para desarrollar FRA fueron la edad > 65 años (OR 12.6; IC95 1.6-105.9, p = 0.03); la presencia de anemia (OR 7.5; IC95 1.8-31.2, p = 0.006); y una duración de procedimiento mayor a 90 minutos (OR 16; IC95 3.1-85.3, p = 0.001). Se observó mayor mortalidad en el grupo NIC (30 versus 1.6%, p = 0.004). Conclusiones: La incidencia reportada es mayor que la literatura. Los factores de riesgo asociados más importantes fueron la edad > 65, anemia y procedimiento > 90 minutos. El desarrollo de NIC conlleva una mayor mortalidad.